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Evaluation and Validation of Endogenous Markers for the Assessment of CYP3A Activity in Korean Healthy Subjects Using Metabolomics

NCT02579434 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2016-04-19

No results posted yet for this study

Summary

The study objective is to evaluate and validate of endogenous markers for the assessment of CYP3A activity in Korean healthy subjects using metabolomics.

In part 1, total 75 healthy subjects (males and females) will be enrolled. In part 2, total 25 healthy female subject aged 20-45 years will be enrolled. In both part A and B, subjects will be administered midazolam I.V. 1 mg.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Midazolam I.V.

Midazolam I.V. 1mg/ml

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-05-31
Completion
2016-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02579434 on ClinicalTrials.gov